GDF2025 - D2S02- Nitrosamine Related Guidance

Описание: This presentation provided an overview of the current regulatory landscape surrounding nitrosamines and the latest guidelines and recommendations from a regulatory perspective regarding nitrosamine detection, risk assessment, and mitigation strategies.

Timestamps

01:12 – Historical Background

03:05 – What are Nitrosamines?

05:06 – Introduction to Nitrosamine Guidance

07:29 – Evolution of FDA Guidance on Nitrosamine Impurities

11:42 – New Recommendations for Nitrosamine Controls

16:54 – Timelines and Updates

20:58 – Takeaways

Speaker:

Reynolds (Rey) Cantave, PharmD
Senior Regulatory Health Project Manager
Enterprise Project Management Staff
Office of Quality Assurance (OQA)
Office of Pharmaceutical Quality (OPQ) | CDER

Learn more at: https://www.fda.gov/drugs/news-events...

-----------------------

FDA CDER’s Small Business and Industry Assistance (SBIA) educates and provides assistance in understanding the regulatory aspects of human drug products & clinical research.

Upcoming Training - https://www.fda.gov/cdersbia
SBIA Listserv - https://public.govdelivery.com/accoun...
SBIA 2024 Playlist -    • 2024 CDER Small Business and Industry Assi...  
SBIA 2025 Playlist -    • 2025 CDER Small Business and Industry Assi...  
SBIA LinkedIn -   / cder-small-business-and-industry-assistance  
SBIA Training Resources - https://www.fda.gov/cdersbialearn
Twitter -   / fda_drug_info  
Email - [email protected]
Phone - (301) 796-6707 I (866) 405-5367